Actively Recruiting
Gestational Diabetes - PrEvention of PostPartum Diabetes Study
Led by Vastra Gotaland Region · Updated on 2024-06-13
600
Participants Needed
1
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gestational diabetes is the most common metabolic abnormality during pregnancy. In a Swedish population 2-10% of all pregnant women are diagnosed with gestational diabetes mellitus (GDM). The frequency differs dependent of methods for screening and diagnostic references, even within Sweden. Women with GDM have about 50% risk to develop manifest type 2 diabetes (T2DM) within 20 years. Most counties in Sweden have a recommendation to follow women with GDM yearly with an examination and an oral glucose tolerance test (OGTT). Unfortunately, this recommendation often fails, partly due to limited resources at the health care units but also due to lack of compliance from the women. Often after the baby is born focus is changed from the mother to the child and only 30.7% of the women with one or more risk factors performed an OGTT, despite stipulated OGTT in local guidelines. The diagnose GDM is under debate and Sweden has started to implement the recommendations from World Health Organisation (WHO) from 2013 with a lower cut-off for GDM, which will increase diagnostic sensitivity and consequently increase the number of women diagnosed with GDM. The plan was to conduct a randomized, clinical trial testing implementation the new recommendations in Sweden step-wise from 2018 and onwards. The recruitment is now complete and the results are expected to be published in 2021. The overarching aim of this study is to conduct a randomized, controlled clinical trial to test the effect of a model for a lifestyle intervention in clinical practice, using technical support as well as personal, individual support. The intervention is based on the existing organisation and structure in Primary Care and would thus be inexpensive and straight-forward to implement. An additive aim is to explore background mechanisms for the development of type 2 diabetes in women with gestational diabetes.
CONDITIONS
Official Title
Gestational Diabetes - PrEvention of PostPartum Diabetes Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with gestational diabetes
- Provided signed informed consent
- Expected to participate in regular child health care visits
- Have internet access via computer, tablet, or phone
You will not qualify if you...
- Have diabetes mellitus diagnosed before pregnancy
- Have other conditions or treatments affecting blood glucose control (e.g., endocrine disorders, cortisone medication)
- Suspected type 1 diabetes based on antibodies or clinical history
- Currently participating in another research study that may interfere
- Have other diseases or conditions that prevent participation according to the Principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maternity Ward, Västra Götaland
Skövde, Sweden
Actively Recruiting
Research Team
M
Margareta I Hellgren
CONTACT
B
Bledar P Daka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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